a safety confirmation study on lenalidomide with dexamethasone in japanese patients with previously treated multiple myeloma

Conditions: Multiple Myeloma

Summary: to evaluate the safety and efficacy of lenalidomide with dexamethasone in japanese patients with previously treated multiple myeloma.


Eligibility criteria:
inclusion criteria: * must understand and voluntarily sign the informed consent form * age ≥ 20 years at the time of signing the informed consent form * subjects with previously treated multiple myeloma defined as follows: * subjects must have received at least 1 prior anti-myeloma drug treatment regimen; and * considered to have progression of disease (pd) that occurred either during or following the completion of the last anti-myeloma treatment regimen utilized prior to enrollment into this study * measurable levels of m-protein in serum (greater than or equal to 0.5 g/dl \[5g/l\]) or urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample) * eastern cooperative oncology group (ecog) performance status of 0 - 2 * must be able to adhere to the study visit schedule and other protocol requirements * females of childbearing potential (fcbp) must agree to use one or more of the following forms of contraception or abstain from heterosexual contact completely and have the male partners use a condom on the occasion of heterosexual contact in the following periods below: * for at least 28 days before starting study drug (in particular, the subject must abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide). * during the treatment phase (including the dose withholding period) for at least 28 days after the discontinuation/completion of the study drug (methods of contraception) * birth control pills * intrauterine device (iud) * bilateral tubal ligation (fcbp must be referred to a health care provider who is familiar with contraceptive methods, if needed). * male subject must agree to use a condom during sexual contact with female irrespective of pregnancy potential * subjects must agree that study drug must be immediately discontinued, if pregnancy or a positive pregnancy test does occur in a female study subject or the partner of a male study subject during study participation exclusion criteria: * pregnant or lactating females * subjects with a history of acute myocardial infarction within the past 6 months before starting the study drugs * subjects with any history or concurrent conditions of deep vein thrombosis or pulmonary embolus within the past 3 years before starting study drugs * subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases * subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma * subjects with posterior subcapsular cataracts * subjects with peripheral neuropathy of ≥grade 2 * subjects with any history or concurrent conditions which the principal investigator / subinvestigators consider inappropriate for participation in this study, and subjects with a serious disease or a mental disease, which is considered to become more risky if the subjects participate in this study. * subjects with a history of desquamative (blistering) rash while taking thalidomide * subjects with a history of using lenalidomide * subjects who have used thalidomide within 28 days before starting the study drugs * subjects with a history of hypersensitivity to dexamethasone * subjects who discontinued treatment due to grade 3 or 4 toxicity from high dose dexamethasone * subjects with a surgical wound after a visceral surgery performed recently * subjects who have undergone radiation therapy within 14 days before starting the study drugs * subjects who have used a chemotherapeutic agent, an immunomodulating agent or a study drug (a drug not commercially available) intended for the treatment of multiple myeloma (mm) within 28 days before starting the study drug * subjects with any history or concurrent conditions of malignancies, other than mm, unless the subject has been free of the disease for 3 years: * basal cell carcinoma of the skin, * squamous cell carcinoma of the skin, * carcinoma in situ of the cervix, * carcinoma in situ of the breast, * incidental histologic finding of prostate cancer tumor, lymph nodes, metastasis (tnm) stage of t1a or t1b) * known human immunodeficiency virus (hiv) infection or hiv-1 positivity * subjects who have been diagnosed as an hepatitis b virus (hbv) carrier * subjects who are applicable to any of the following abnormal laboratory findings: * absolute neutrophil count : \< 1,000 /μl (1.0×10\^9 /l) * platelet count: \<75,000 /μl (75×10\^9 /l) * aspartate aminotransferase (ast)/serum glutamic oxaloacetic transaminase (sgot) or alanine aminotransferase (alt)/serum glutamic-pyruvic transaminase (sgpt): \> 3.0 times the upper limit of the standard range * creatinine clearance: \< 30 ml/min